Limitations of head-up tilt test for evaluating the efficacy of therapeutic interventions in patients with vasovagal syncope: results of a controlled study of etilefrine versus placebo
Open accessAbstract
Objectives This study assessed the efficacy of oral etilefrine (10 mg three times a day) in preventing a positive response to head-up tilt testing.Background Previous reports have suggested that oral etilefrine can be effective either in preventing a positive response to head-up tilt testing or in reducing syncopal recurrences in patients with vasovagal syncope. Up to now most studies assessing drug therapy in these patients have been uncontrolled.Methods This was a randomized double-blind crossover study of etilefrine versus placebo in 30 consecutive patients with syncope and a baseline positive head-up tilt test. After the first test, patients had no treatment for 3 days and were randomized to receive etilefrine or placebo for 4 additional days. They underwent tilt testing under treatment and again after 3 days of washout; they then received the alternative treatment for 4 days, and a third test was performed.Results Head-up tilt test results were negative in 13 (43%) patients with etilefrine and 15 (50%) with placebo (p = NS). Therefore, the statistical power of the study was only 10%. The rate of positive responses decreased with repeated testing irrespective of the assigned treatment: A positive response was obtained during the second head-up tilt test in 20 patients (10 with placebo, 10 with etilefrine) but in only 12 during the third (7 with etilefrine, 5 with placebo) (p < 0.05).Conclusions Oral etilefrine (10 mg three times a day) was not superior to placebo in preventing a positive response to head-up tilt testing. Despite a low statistical power, the high rate of negative response with placebo (50%) suggests that controlled trials are needed to assess the real efficacy of any treatment in patients with vasovagal syncope.
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Tilt testing has limited value in assessing treatment efficacy.
“Tilt testing has limited value in assessing treatment efficacy. 118”
From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [118]
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References 31 · Cited by 151
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- Authors
- Moya, A., Permanyer-Miralda, G., Sagrista-Sauleda, J., Carne, X., Rius, T., Mont, L., & Soler-Soler, J.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 1995-01
- Volume
- 25
- Issue
- 1
- Pages
- 65-69
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W2032118512
- Cited by
- 151
- References
- 31
- Citations by year
- 2026: 1 · 2025: 4 · 2022: 1 · 2021: 2 · 2020: 1 · 2019: 1 · 2018: 2 · 2017: 8 · 2016: 1 · 2015: 3 · 2014: 3 · 2013: 9 · 2012: 4
- FWCI
- 13.78
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
- Life Sciences › Neuroscience › Neurology › Vestibular and auditory disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
- Keywords
- vasovagal syncope, head-up tilt, etilefrine, drug efficacy, placebo response, statistical power, treatment response variability
- MeSH terms
- Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Double-Blind Method, Etilefrine, Female, Humans, Male, Middle Aged, Placebos, Syncope, Chi-Square Distribution, Cross-Over Studies, Tilt-Table Test
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